Chhattisgarh Drug License

Chhattisgarh Drug License

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Chhattisgarh Drug License

Chhattisgarh drug license is a document of permission for carrying out businesses related to pharmaceutical industries that deal with drugs, medicines and cosmetics. The government of Chhattisgarh issues drug license to regulate the manufacture, storage, distribution and sales of drugs. Chhattisgarh drug license issues under the Drug and Cosmetics Act, 1940 to a person dealing with drugs. As per this act, it is essential to get a Chhattisgarh drug license before the launching the drug business. In this article, we will look at the procedure for obtaining Chhattisgarh drug license in detail.

Know more about How to start a pharmacy business

Drugs and Cosmetics Act

Chhattisgarh drug license is crucial according to the Drugs and Cosmetics Act; 1940. This act moderates the manufacture, distribution import and sale of drugs and cosmetics which includes homoeopathic medicines, allopathic drugs and even the Ayurvedic, Siddha or Unani drugs.

Importance of Chhattisgarh Drug license

Some of the significance of Chhattisgarh drug license is explained in detail below:

  • The Chhattisgarh drug license permits market, manufacture sale, resale, trade of drug and cosmetics.
  • Without a Chhattisgarh drug license, no person can do pharmacy business or even start to associate with any dealings in Chhattisgarh.
  • For protecting good health of our nation through adequately accessing the medicines and drugs, the Drugs and Cosmetics act made it mandatory for obtaining a drug license
  • Chhattisgarh drug license also ensure that the drug and drugs are not misused or abused by any individuals in Chhattisgarh
  • Dealing with drugs a without a drug license is a cognizable offence. Every trader in the pharmacy industry needs to have their drug incense to carry out their day-to-day business work.
  • Chhattisgarh drug license contains the rules and regulation for the person who is dealing with drugs business

Note: It is the responsibility of all individuals dealing with medicine, drugs and cosmetics to maintain its quality. If any person consuming a drug or medicine suffers any harm from the negligence on the part of the seller or manufacturer of the medicine, the same is an offence, which is an offence of grievous hurt under IPC. Hence holding Chhattisgarh drug license is necessary.

Who needs Chhattisgarh Drug License?

Chhattisgarh drug license is mandatory for dealing with the following type of business. Any individual, partnership firm, limited liability company, corporation or business firm located In Chhattisgarh and is physically distributing the drugs in the state is required to hold a drug license.

  • Business with any cosmetics intended to be sprinkled, rubbed, poured or introduced into the human body or for beautifying, cleansing, promoting attractiveness, or altering the appearance of a human, must obtain Chhattisgarh Drug license.
  • It is vital to get a drug license to deal with medicine/drug which is used for internal or external in human beings
  • Manufacturing and distribution drugs or cosmetics applied to the human body to repel insects like mosquitoes also need Chhattisgarh drug license.
  • Business with medicines used for the destruction or insects which cause diseases in human beings must obtain a drug license.
  • Chhattisgarh drug license also needed for dealing with empty gelatine capsule.
  • To manufacture, store and distribute the drugs used for diagnosis, mitigation, treatment or prevention of disease or disorder in humans or animal, need Chhattisgarh drug license

Know more about the Medicine and drugs allowed for import without a licence

Basic Requirement for Obtaining Chhattisgarh Drug License

According to the provision of Drug and cosmetics act, 1940 to get a Chhattisgarh drug license the below-mentioned requirements to be met by the trader.

Area Recruitment

The minimum area required for setting up a medical shop or pharmacy is ten square meters. In case of the store business combination with the retail and wholesale than the minimum area of fifteen square meters is needed.

Storage Facility

It is crucial to have an air conditioner and refrigerator on the premises because some medicines such as insulin injections, vaccines are needed to be stored in the refrigerator.

Technical Staff

Sale of medicines should be carried in the presence of a registered Pharmacist approved by the Chhattisgarh Government who is needed throughout the working hours in the retail shop.

The wholesale of drugs can be made either by a registered pharmacist or any competent authority who graduate and having one year of experience in drugs or in the presence of an of person who has passed SSLC having experience of four years in drugs business, specially approved by medical, health and family welfare department.

Classification of Chhattisgarh Drug License

Based on the requirement of the pharmaceutical or drug business, Chhattisgarh Drug License can be classified in the following categories:

  • Sale License
  • Manufacturing License – Blood Bank

Sale License

Sale license is issued to persons or agencies engaged in the sales of drugs or medicines in Chhattisgarh. The sale drug license can be further classified into the following two types.

  • Retail License: It is provided to run and sell drugs or drug products in Chhattisgarh.
  • Wholesales License: It is issued to a person or agency engaged in wholesale of medicine or drugs

Manufacturing License

Manufacturing license is issued to a person or agencies involved in the manufacturing of drugs or medicines and cosmetics. Government also issued Manufacturing loan license. This loan license will be issued to licensee or person using the premises, equipment and staff of another drug licensee having a manufacturing drug license.

Application Processing Time

Timeline for grant and renewal of Chhattisgarh drug retail sales, wholesale and drug manufacturing license will be one month from the date of application.

Prescribed Authority

Licensing Authority of the Department of Health & Family Welfare and Medical Education, Government of Chhattisgarh issues sale drug license as per the provisions of drug and cosmetics act.

The manufacturing drug license will be issued by the Licensing authority of Controller Food and Drugs Administration, Government of Chhattisgarh.

Applicable Fee

The fee structure for Chhattisgarh drug license will be varied according to the type of drug license.

S.NoType of Chhattisgarh drug licenseFee Structure
1New Retail Drug LicenseRs. 3000
2New Wholesale Drug LicenseRs.3000
3New Manufacturing Drug LicenseRs. 7500 per application and fees for the additional fee of Rs.300 per item

The detailed fee structure is available in the Drugs Control Media Services webpage.

Documents Required

Following documents need to be provided for Obtaining Chhattisgarh Drug license.

Documents for New Retail Drug License

  • Application
  • Challan Copy
  • Affidavit of the proprietor on stamp paper of Rs.20
  • Self-attested educational certificate copies of the proprietor
  • Self-attested copies of Identity proof of proprietor such Domicile certificate, Driving license, Voter ID card
  • Affidavit of Registered Pharmacist
  • Self-attested educational certificate copies of Registered Pharmacist
  • Self-attested copies of Identity proof of registered pharmacist such as Domicile certificate, Driving license or Voter ID card
  • Blueprint of plan layout of proposed area or premises
  • Electricity bill of proposed area premises
  • Copy of Refrigerator bill
  • Rent agreement on Rs.50 stamp paper
  • Ownership documents of the premises including the copy of tax receipt of proposed area
  • Covering letter
  • Photograph of 5-5 each of registered pharmacist and proprietor

Documents for New Wholesale Drug License

  • Application
  • Challan Copy
  • Affidavit of the proprietor on stamp paper of Rs.20
  • Self-attested educational certificate copies of the proprietor
  • Self-attested copies of Identity proof of proprietor such Domicile certificate, Driving license, Voter ID card
  • Affidavit of Competent person
  • Self-attested educational certificate copies of a Competent person
  • Self-attested copies of Identity proof of Competent person such as Domicile certificate, Driving license or Voter ID card
  • Experience certificate of a competent person. (Experience certificate of four years after 12th or experience certificate of 2 years after graduation in original)
  • Blueprint of plan layout of proposed area or premises
  • Electricity bill of proposed area premises
  • Copy of Refrigerator bill
  • Rent agreement on Rs.50 stamp paper
  • Ownership documents of the premises including the copy of tax receipt of proposed area
  • Covering letter
  • Photograph of 5-5 each of registered pharmacist and proprietor

Note: All supporting documents should be in PDF format scanned in GRAY scale.

Documents for New Manufacturing Drug License

Documents required for obtaining Chhattisgarh manufacturing drug license is attached in the document here:

Document

Chhattisgarh Drug License Application Procedure – Retail and Wholesale

The procedure to obtain sale drug license in Chhattisgarh is explained in step by step procedure here:

Access XLNINDIA

Step 1: Applicant needs to visit the XLNINDIA homepage. From the home page select Chhattisgarh from the drop-down menu and click on sales login button.

Image 1 Chhattisgarh Drug License
Image 1 Chhattisgarh Drug License

Registration

Step 2: The link will redirect to click on Close button new page. In this page apply for User ID and Password. You will get the user ID and Password on the Registered Mobile number.

Image 2 Chhattisgarh Drug License
Image 2 Chhattisgarh Drug License

Step 3: After obtaining user credential, login to the portal by entering the username and password. Click on the submit button.

Login to Portal

Step 4: Once you login to this portal, you can change the password for privacy and security. The option for changing the password is available on right top corner.

Image 3 Chhattisgarh Drug License
Image 3 Chhattisgarh Drug License

Step 5: After providing a password, click on update my details (available on the left top corner of the screen) and correct it, if required. Once the application is corrected, click on update option to proceed further.

Provide Details

Step 6: Go to the menu and click on Prepare/edit online application option.

Step 7: After that click on new inward (available on the right top corner of your screen) option, click on Ok button.

Step 8: Select the Storage type from the drop-down menu. You have to select at least one from the list. (Compulsory)

Step 9: You need to select the document type from the drop-down menu and select the Aadhaar Card and provide Aadhaar Number in the space provided.

Step 10: You have to select the inward type option from the drop box and select Fre-add/Fresh license option. Click on the RP in Retail & CP in Wholesale button.

Note: It is not required for Form 20C & 20A/21A

Step 11: By clicking on the ADD button, you can provide all details for Chhattisgarh drug license.

Upload Documents

Step 12: Upload all supporting documents (refer above) and photographs. The certificate should consist of registration certificate of a pharmacist from state pharmacy tribunal and current renewal. After uploading the required documents click on the save button.

Step 13: You can provide all other details by clicking on the CON button and then on the ADD button.

Step 14: Take the print out of self-declaration of RP or CP and proprietor. Get it signed by a registered pharmacist and proprietor or authorized signatory.

Step 15: By following the same method, you can upload all other documents when required.

Step 16: After uploading documents, click on the Back button. In the new page, click on by firm and print application form.

Note: Keep the printed application safe for uploading with other documents when required.

Payment of fee through E-payment Gateway

Step 17: Make the payment through the e-payment gateway option available in the portal. Once the payment is successful e-challan will be displayed. Take the print out of the e-challan for uploading.

Upload Challan

Step 18: After receiving the challan receipt, login to the portal for uploading e-Challan. After login to portal Click on By Firm option. Select payment entries and click on New.

 Step 19: Select payment type as FRAS Payment and fill all required details. Upload the scanned copy of deposited challan by using ‘Choose file’ option and click on Save.

Step 20: Click on upload option for uploading all other required documents then click on Close button.

Additional information/Undertaking

Step 21: Click on Additional information/Undertaking option. Fill all details and click on s-sign button. Select the additional form information button and then on the Back button.

Forward Application to licensing authority

Step 22: Certify and e-Send Application to Department, i.e. the licensing authority. Licensing authority will forward the application to Drug Inspector within five working Days for verification.

Site Verification by Drug Inspector

Step 23: The drug inspector will verify the document and premises, and Drug Inspector will submit his report to the Licensing Authority within 15 working.

Step 24: After viewing the report the licensing authority will grant or reject the License within ten working days.

Status of Application

 Applicant should log in frequently to check the status of Application in the dashboard. Application Status will also be available in the INBOX to see if any query raised by the Department and should reply accordingly.

Print License

 By login, to the portal, you can print the Chhattisgarh drug license. It needs to be printed within three days from the date of issue.

Chhattisgarh Drug License Application Procedure – Manufacturing

The procedure to obtain manufacturing drug license in Chhattisgarh is explained in step by step procedure here:

Step 1: Visit the home page of Controller Food and Drugs Administration, Government of Chhattisgarh. From the main page, click on the Drug License option, the link will redirect to the new page.

Image 4 Chhattisgarh Drug License
Image 4 Chhattisgarh Drug License

Registration

Step 2: In the new page select the option ‘Drugs & Cosmetics License/Registration’. The registration application form will be displayed.

Image 5 Chhattisgarh Drug License
Image 5 Chhattisgarh Drug License

Step 3: After providing all the details Click on register option.

Image 6 Chhattisgarh Drug License
Image 6 Chhattisgarh Drug License
Image 7 Chhattisgarh Drug License
Image 7 Chhattisgarh Drug License

Login to Portal

Step 4:  Applicant should log in to the portal through ID created by him/her.

Image 8 Chhattisgarh Drug License
Image 8 Chhattisgarh Drug License

After Login the dashboard will be displayed, and the Applicant has to click on Apply for New License option.

Image 9 Chhattisgarh Drug License
Image 9 Chhattisgarh Drug License

Provide Details

Step 5: Application form for Chhattisgarh drug license will be displayed, and the applicant has to fill the required details. Provide following details in application form.

  • Company details
  • Manufacturing Premises details
  • Enter product
  • Technical staff details
  • Machinery & equipment details

Image 10 Chhattisgarh Drug License
Image 10 Chhattisgarh Drug License

Manufacturing Premises details

Provide the details of drug manufacturing place and premises.

Image 12 Chhattisgarh Drug License
Image 12 Chhattisgarh Drug License

Enter product Details

Applicant should select the desired dosage form to be manufactured example Tablet, Syrup etc. and entry should be done.

Image 13 Chhattisgarh Drug License
Image 13 Chhattisgarh Drug License

Provide Technical staff details

Details of Technical Manpower should be provided responsible for Manufacturing, Analytical and Quality Assurance in the premises.

Image 14 Chhattisgarh Drug License
Image 14 Chhattisgarh Drug License

Machinery & equipment details

The applicant needs to enter all the details of the manufacturing unit machinery & equipment details.

Image 16 Chhattisgarh Drug License
Image 16 Chhattisgarh Drug License

Upload Supporting Document

Step 6: You need to upload the documents for the manufacturing license as stated above.

Image 17 Chhattisgarh Drug License
Image 17 Chhattisgarh Drug License

Step 7: After providing the details in the application, click on the save button and payment should be done through e-challan.

Image 18 Chhattisgarh Drug License
Image 18 Chhattisgarh Drug License

Note: If the Applicant wants to edit the details, he/she should click on the edit option and can easily edit the details before Final Submission.

Final Submission

Step 8:  After providing all the details, the applicant should download Auto-generated forms and should upload the signed form in the upload option and Click on the final submit option.

Image 19 Chhattisgarh Drug License
Image 19 Chhattisgarh Drug License

Site Verification by Drug Inspector

Step 9: The Site will be verified by Drugs Inspector as per the Drugs and Cosmetics Act 1940 and Rules 1945 within 20 days from the date of issue.

Step 10: The drug inspector will forward the report to the Licensing Authority. After viewing the report the concerned licensing authority will grant or reject the License within ten working days.

Status of Application

 Applicant should log in frequently to check the status of Application in the dashboard. Application Status will also be available in the INBOX to see if any query rose by the Department and should reply accordingly.

Print License

By login, to the portal, you can print the Chhattisgarh drug license. It needs to be printed within three days from the date of issue.

Image 20 Chhattisgarh Drug License
Image 20 Chhattisgarh Drug License

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